Trial Information

Summary: This is a study to evaluate the effectiveness of Tarceva ® (erlotinib) tablets vs. placebo (sugar pill) following complete surgical removal of the tumor with or without chemotherapy after surgery in IB-IIIA NSCLC patients.

Purpose
The purpose of this study is to evaluate the effectiveness of Tarceva vs. placebo following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA non-small cell lung cancer (NSCLC) patients who have EGFR-positive tumors. Patients will be assigned by chance (2:1), to receive either Tarceva or placebo.

Condition
Stage IB-IIIA NSCLC

Intervention
Drug: Erlotinib (Tarceva)

Phase
Phase III

Study Type
Interventional

Study Design
Treatment, Randomized, Double-blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva ® (erlotinib) Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non-small Cell Lung Carcinoma who have EGFR-positive Tumors (RADIANT)

Further study details as provided by OSI
Primary Outcome: The primary goal of this study is to show that Tarceva following complete tumor resection increases the disease free survival (DFS) in patients with EGFR-positive tumors as compared to those patients who received placebo.

Secondary Outcomes:

• Compare the overall survival (OS) by study arm (Tarceva vs. placebo)
• Evaluate the safety of Tarceva
• See how genes and proteins affect different people when they take drugs like Tarceva.

Expected Total Enrollment: 945

Study Start: August 2006

Eligibilty
Ages Eligible for Study: 18 Years and above

Genders Eligible for Study: Both

Main Inclusion Criteria

• Complete removal of the tumor by surgery.
• Confirmed diagnosis of Stage IB-IIIA NSCLC.
• Primary tumor tissue from patient's surgery must be EGFR-positive by certain tests.
• Patients may have up to 4 cycles of chemotherapy after surgery.
• Able to start drug under following timelines: 6 months from the day of surgery for patients who get chemotherapy and 3 months from the day of surgery for those who do not get chemotherapy.
• Patients must be accessible for follow-up visits.

Main Exclusion Criteria

• Tumors with mixed histology of NSCLC and SCLC. Patients with carcinoid tumors are not eligible.
• History of prior radiotherapy for NSCLC either before or after surgery.
• Patients who have received chemotherapy for NSCLC before surgery.
• History of heart disease or uncontrolled heart arrhythmias within the previous year.
• History of poorly controlled GI disorders that could affect the absorption of study drug.
• History of other cancer except certain skin or cervical cancers. Patients who have had other cancer are eligible if they have remained disease free for at least 5 years.

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.